MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 50°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	APOLLO RF 50°
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-9815 apollorf mp50 aspirating ablator plastic end came part from the probe.This was discovered during a procedure on (b)(6) 2023.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
Additional information received on 2/13/2023: this was discovered during a hip labrum repair procedure on (b)(6) 2023.While the surgeon was using the ablator, the plastic near the metal head, cracked off inside the patient.Surgeon removed all broken fragments and opened a new r-9815 apollorf mp50 aspirating ablator to complete the case.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to a user error by prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: APOLLO RF 50°
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16444622
• Report Number: 1220246-2023-06359
• Device Sequence Number: 5544408
• Product Code: GEI
• UDI-Device Identifier: 00888867142527
• UDI-Public: 00888867142527
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APOLLO RF 50°
• Device Catalogue Number: AR-9815
• Device Lot Number: 2112021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown